successful label tracking · 2019. 8. 22. · case study freyr. project in scope & business...
TRANSCRIPT
SUCCESSFUL
LABEL TRACKINGDATA MIGRATION&
company/freyr-solutions www.freyrsolutions.com | [email protected]
®
CASE STUDY
www.freyrlabel.com
Freyr
PROJECT IN SCOPE & BUSINESS IMPERATIVES
FREYR’S SOLUTIONS AND SERVICES
Large Global Pharmaceutical Company
Label Tracking and Data Management for Multiple Product Categories/Portfolios and 50,000+ Tracking Records and Additional Downstream System Datasets
Transformation and Migration of Change Control, Labeling, Artwork and Supply Chain Systems from Multiple Sources to a Single Tracking System
Ensuring Smooth Cutover and Process Transition as per Compliance Standards
Multiple Data Movement Strategies (Portfolio/ Source/ Scope/ Complexity)
Migration Requirements & Plans
Mapping & Rule Books
Work Instructions, Templates
Protocols, Scripts, Checklists
Summary Reports
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Data Entry Cycle – 1 Ini�al Data Load & 1 Differen�al (Delta) Load
Business
Extract & Compile Data Sheets for Ini�al Data & upload to Source Data
folder
Source Data Sheets
(Ini�al Data)
Data Entry & Verifica�on
(Source to Staging) for Ini�al Data
T0
Follow interim process with changes to source
data highlighted or iden�fiable
T1
T1B
Extract & Compile Data Sheets for Differen�al Data & upload
to Source Data folder
Source Data Sheets
(Differen�al Data)
T3
Data Entry Team
Data Entry & Verifica�on
(Staging to ) for Ini�al Data
T2
Data Entry & Verifica�on
(Source to Staging) for Differen�al Data
Business Verifica�on on for Ini�al
Data
Data Entry & Verifica�on
(Staging to ) for Differen�al Data
T5
Business Verifica�on on for
Differen�al Data
T5B
Business Verifica�on on Staging for Ini�al
Data
Staging Data Sheets (Ini�al Data)
Staging Data Sheets (Differen�al
Data)
Data (a�er Ini�al
Load)
Data (a�er
Differen�al Load)
Business Verifica�on on Staging for
Differen�al Data
T2B
T4
T4B
Ini�al Load Steps Differen�al Load Steps
Suggested Freeze on Source Data:Any tracking data generated during Differential Load between T3 to T5B to be entered directly in after T5B
Mutli-complexity Data Workstreams
Movement Strategies and Processes
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Take the reason from column “Reason for non-submission” of SP-Impact Assessment sheet
Enter in column "Reason(s): If "No Submission/Notification Required"" of Tracking sheet
Sheet/Column in COMPLIANCE TRACKER Sheet/Column in Staging Data Sheet
SP-Impact Assessment / Reason for non-submission
Tracking / Reason(s): If "No Submission/Notification Required"
1.1.1.1. Entering data regarding dependency under Country Administration
a) Entering Brief Change/Save Reason Description Text
Please refer Data Entry Rule Book for the associated business rule.
b) Entering Tracking Path
Please refer Data Entry Rule Book for the associated business rule.
c) Entering Start Tracking Date
Please refer Data Entry Rule Book for the associated business rule.
d) Entering Final Tracking Date
Please refer Data Entry Rule Book for the associated business rule.
e) Entering Dependent On Milestone/Tracking Date
Take the dependent milestone from column “Dependent On Milestone/TrackingDate” of SP-Reference Countries Sheet.
Enter it in column “Dependent On Milestone/Tracking Date” of Tracking sheet.
Mapping and Rule Books
Work Instructions
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DATA COLLECTION
Milestones completion, compliance
Quantitative Summaries
Data Quality Dashboards
3Sectors
, Consumer, Pharma
14Workstreams
Data Entry Work streams Pharma Global,
Consumer Global etc.
40+Data Sources
Analyzed Data Sources systems, trackers etc.
42,000+Data Volume
~ Data Volume in Scope Global and Country records
550+Data Elements
Sources, intermediates, Trackers and Target
250+Data Rules
Data Mapping & Business Transforma�on Rules
600+Issues
Gaps, Inconsistencies, Queries etc.
500+Issues Closed
Driven to decisions, rules, correc�ons etc.
200+Resolu�ons
Freyr Provided recommenda�ons, solu�ons
100+Issues OpenPending resolu�on
Quan�ta�ve Summary of Data scope, Quality, Complexity, Volume, Open and Resolved Issues
Quantitative Summaries
Qualitative Dashboards
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STAGING AND VALIDATION
Staging Data Sheets (manual)
Data Import Logs (automated)
Validation Checklists
LIFT ACTELION DATA ENTRY SOURCE TO STAGING VERIFICATION CHECK LIST
Source & Verification Details
Sector / Cycle Actelion Cycle __ (1/2)
Type of Change ☐ Global CCDS Safety Change ☐ Locally Initiated Safety Change ☐ Global CCDS Non-Safety Change
Source ID (Parent record) (1 Checklist per parent record and related child records included)
Verification Run ID (1st run starts with 01)
Source Data Location & Filename
Staging Data Location & Filename
S. No. Item Description Yes No Issues found/ Comments
A Staging Data Sheet: Request
1. Origin verified as per business rule? ☐ ☐
2. Request Topic verified as per business rule? ☐ ☐
3. Request Description verified as per business rule? ☐ ☐
4. Priority verified as per business rule? ☐ ☐
5. Day 0/Decision to start note verified as per business rule?
☐ ☐
6. CCDS LC Sign Off note verified as per business rule?
☐ ☐
7. Target Submission Date note verified as per business rule?
☐ ☐
8. Target Submission Date Timeline Extension note verified as per business rule?
☐ ☐
9. Target Submission Date Timeline Extension reason verified as per business rule?
☐ ☐
10. Legacy Tracking Number verified as per business rule?
☐ ☐
Request Sheet verified with no issues? ☐ ☐
B Staging Data Sheet: Request Text
1. Request Text ID verified as per business rule? ☐ ☐
2. Request Text verified as per business rule? ☐ ☐
Request Text Sheet verified with no issues? ☐ ☐
Validation/Quality Checklists
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MIGRATION AND QC
CLIENT BENEFITS
Migration Logs & Summary Reports
QC Reports & Analysis
50,000+ Tracking Records Qualitative Summaries Periodical Validation
and Quality Checklists
Page 37 of 96
GLENMARK PHARMACEUTICALS LIMITED MIGRATION SUMMARY REPORT
Document No.:
RADMS_MSR_027
Change Control: CCI000170588
Computerized System for:
LABELLING DOCUMENT MANAGEMENT SYSTEM
Head Office, Mumbai
Version No: 01 Page 37 of 96
Phase Migration Input File # Round Start Date/End Date/executed by/ verified by
Migration Results Re-run 1% Sample Verification post run
1
Pharma_Global_Chang
es_2015-16.xlsx
1 Start Date:29-Sep-2017 End Date:29-Sep-2017. Executed By: Kishore Kumar.H Verified By : Kamalteja Konidena Verification Start Date:29-Sep-2017 Verification End date-29-Sep-2017
Completed; with 0 errors(s)
NA Sample Size:32 Passed: 32 Failed:0
A Single-stop Comprehensive Tracking System
Smooth Transition and Compliance
Migration Summary Reports
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Freyr is a leading, niche, end-to-end global Regulatory solutions and services company supporting large, mid, and small global organizations across different life sciences verticals - Pharmaceuticals | Generics | Medical Devices | Biotechnology | Biosimilars | Consumer Healthcare | Cosmetics | Nutraceuticals. Freyr supports life sciences organizations in their entire Regulatory value chain - Intelligence Driven Submissions/
Product Registrations | Labeling | Artwork | Post- Approval Change Management | Regulatory Software and other related services.
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